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Benefits of Microcor in Ambulatory Decompensated Heart Failure (BMAD-TX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096040
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

Brief Summary:
To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

Condition or disease Intervention/treatment Phase
Heart Failure Device: μCor Not Applicable

Detailed Description:

Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days.

During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events.

The subject will be given a daily diary to track symptoms, hospital visits, medication changes, and all other heart failure related clinical events.

Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events.

The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators.

Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of μCor wear, and any health care utilization since the end of μCor wear.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Benefits of Microcor in Ambulatory Decompensated Heart Failure
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Device Data Engagement Assessment
This arm will assess the endpoints of investigator engagement with the device data.
Device: μCor
μCor consists of the following components: A) Patch B) Sensor C) Charger D) Data transmission device (Gateway) E) Server Once activated, the wearable Sensor automatically acquires ECG, RF readings, heart rate, respiration rate, activity, and posture measurements.




Primary Outcome Measures :
  1. Investigator Engagement of Device Data [ Time Frame: Through study completion, an average of 2.5 years. ]
    Quantification of investigator actions after viewing device data.


Secondary Outcome Measures :
  1. Correlations of the μCor measured thoracic fluid index to heart failure related clinical events. [ Time Frame: 90 days. ]
    Reading: thoracic impedance index (relative value that is normalized to a baseline radar impedance). Clinical heart failure events will be collected in the Case Report Forms.

  2. Correlations of cardiac rhythm μCor measurements to heart failure related clinical events. [ Time Frame: 90 days ]
    Reading: cardiac rhythm measured as heart rate (beats per minute)Clinical heart failure events will be collected in the Case Report Forms.

  3. Correlations of respiration rate μCor measurements to heart failure related clinical events. [ Time Frame: 90 days ]
    Reading: respiration rateClinical heart failure events will be collected in the Case Report Forms.

  4. Correlations of the μCor measured thoracic fluid index and heart failure related symptoms. [ Time Frame: 90 days ]
    Reading: thoracic impedance index (relative value that is normalized to a baseline radar impedance).Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.

  5. Correlations of cardiac rhythm μCor measurements and heart failure related symptoms. [ Time Frame: 90 days. ]
    Reading: cardiac rhythm measured as heart rate (beats per minute)Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.

  6. Correlations of respiration rate μCor measurements and heart failure related symptoms. [ Time Frame: 90 days ]
    Reading: respiration rate. Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.

  7. Incident Rate; Hospital Readmission [ Time Frame: 90 days, 6 months, 1 year ]
    Rate of hospital readmission captured in the Case Report Forms.

  8. Incident Rate; Physician Visit [ Time Frame: 90 days, 6 months, 1 year ]
    Rate of physician visits captured in the Case Report Forms.

  9. Incident Rate; Outpatient Clinic Visit [ Time Frame: 90 days, 6 months, 1 year ]
    Rate of outpatient clinic visits captured in the Case Report Forms.

  10. Mortality; Rate [ Time Frame: 90 days, 6 months, 1 year ]
    Mortality Rate; number of subject deaths captured in the Case Report Forms

  11. Mortality; Cause of Death [ Time Frame: 90 days, 6 months, 1 year ]
    Cause of Death; clinical history captured in the Case Report Forms

  12. Quality of Life by Patient Security Questionnaire [ Time Frame: 90 days, 6 months, 1 year ]
    Quality of Life; measured through and Patient Health Security Questionnaire.

  13. Quality of Life by Kansas City Heart Questionnaire [ Time Frame: 90 days, 6 months, 1 year ]
    Quality of Life; measured through Kansas City Heart Failure Questionnaire.

  14. Health Care Utilization by Cost Estimate [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through cost estimates of prescription medications.

  15. Health Care Utilization by Frequency of Prescription Medication Use. [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through frequency of prescription medication use reported on the Case Report Forms.

  16. Health Care Utilization by Frequency of Hospital Visits. [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through frequency of hospital visits reported on the Case Report Forms.

  17. Health Care Utilization by Frequency of ER visits. [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through frequency of emergency room visits reported on the Case Report Forms.

  18. Health Care Utilization by Frequency of physician visits. [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through frequency of physician visits reported on the Case Report Forms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
  • 4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
  • 4.1.3 Subjects 21 years of age or older on the day of screening.

Exclusion Criteria:

  • 4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
  • 4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
  • 4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
  • 4.2.4 Subjects anticipated to start dialysis within 90 days.
  • 4.2.5 Subjects currently implanted with an S-ICD system.
  • 4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
  • 4.2.7 Subjects who are unable to participate in all follow up visits.
  • 4.2.8 Subjects participating in research other than a registry at the time of enrollment.
  • 4.2.9 Subjects currently implanted with an LVAD.
  • 4.2.10 Subjects with self-reported pregnancy.
  • 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096040


Contacts
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Contact: Mike Osz 412-968-3472 mosz@zoll.com
Contact: Tara Roberts 412-968-3333 ext 14559 tara.roberts@zoll.com

Locations
Show Show 40 study locations
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
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Study Director: Mike Osz Zoll Medical Corporation
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Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT04096040    
Other Study ID Numbers: 90D0202
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases